Ramoclav

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Ramoclav (Enhancin)
875 mg + 125 mg, film-coated tablets
Amoxicillinum + Acidum clavulanicum
Ramoclav and Enhancin are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Ramoclav is and what it is used for
2. What you need to know before taking Ramoclav
3. How to take Ramoclav
4. Possible side effects
5. How to store Ramoclav
6. Contents of the pack and other information

1. What Ramoclav is and what it is used for

Ramoclav is an antibiotic that kills bacteria causing infections.
It contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called penicillins, whose action may sometimes be inhibited (inactivated). The second active component (clavulanic acid) counteracts this inactivation.
Ramoclav is used in adults and children to treat:

• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections.

2. Important information before using Ramoclav

When not to use Ramoclav:

• if the patient is allergic to amoxicillin, clavulanic acid, penicillin, or any of the other components of this medicine (listed in section 6)
• if the patient has ever experienced severe allergic reactions to any other antibiotic. These may include rash or swelling of the face or neck.
• if the patient has ever had liver function disorders or jaundice (yellowing of the skin) associated with the use of an antibiotic.

If any of the above circumstances apply, the patient should not take Ramoclav. In case of doubt, consult a
doctor or pharmacist before starting Ramoclav.
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Warnings and precautions
Before starting treatment with Ramoclav, discuss with a doctor or pharmacist if the patient:

• has infectious mononucleosis
• is being treated for liver or kidney disease
• has irregular urination.

If in doubt whether any of the above applies, consult a doctor or
pharmacist before starting Ramoclav.
In some cases, the doctor may order a test to determine which type of bacteria caused the infection. Depending on the results, the patient may receive Ramoclav at a different dose or a different medicine.
Conditions to be aware of
Taking Ramoclav may worsen certain diseases or cause serious adverse effects, including allergic reactions, seizures, and colitis. Be vigilant for specific symptoms during treatment with Ramoclav to reduce the risk of adverse effects. See "Conditions to be aware of" in section 4.
Blood and urine tests
If the patient is due to have blood tests (such as red blood cell count or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the patient is taking Ramoclav. Ramoclav may affect the results of these tests.
Ramoclav and other medicines
Tell the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
If the patient takes allopurinol (used to treat gout) at the same time as Ramoclav, the risk of skin allergic reactions increases.
If the patient takes probenecid (used to treat gout), the doctor may decide to adjust the dose of Ramoclav.
If the patient takes anticoagulant medicines (such as warfarin) at the same time as Ramoclav, additional blood tests may be required.
Ramoclav may affect the action of methotrexate (a medicine used to treat cancer and rheumatic diseases).
Ramoclav may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Ramoclav may cause adverse effects that could impair the ability to drive. Do not drive or operate machinery unless the patient feels well.

3. How to use Ramoclav

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This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Adults and children weighing 40 kg or more

• Usual dose – 1 tablet twice daily
• Higher dose – 1 tablet three times daily

Children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with amoxicillin and clavulanic acid in the form of an oral suspension or sachets.
Before administering Ramoclav tablets to children weighing less than 40 kg, consult a doctor or pharmacist.
Patients with kidney or liver disease

• If the patient has kidney disease, the dose may need to be adjusted. The doctor may prescribe a different dose of Ramoclav or another medicine.
• If the patient has liver disease, blood tests should be performed more frequently to monitor liver function.

Route and method of administration

• Swallow the tablets whole with a glass of water, at the beginning of a meal or just before a meal.
• Maintain equal intervals between doses, with at least 4 hours between each dose. Do not take 2 doses within 1 hour.

Duration of treatment
Do not take Ramoclav for longer than 2 weeks. If the patient still does not feel better, they should contact their doctor again.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing in case of difficulty swallowing it whole.
Taking more Ramoclav than prescribed
If you take more Ramoclav than prescribed, symptoms such as irritation of the stomach and intestines (nausea, vomiting, or diarrhoea) or seizures may occur. Consult a doctor immediately. Take the medicine packaging with you so you can show it to the doctor.
Missing a dose of Ramoclav
If you miss a dose, take it as soon as possible. Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
Do not take a double dose to make up for a missed tablet.
Stopping treatment with Ramoclav
Continue taking Ramoclav for the full duration of treatment, even if you start to feel better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Reactions to be aware of
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Allergic reactions

• Rash
• Vasculitis, which may appear as red or purple raised spots on the skin, but may also affect other parts of the body
• Fever, joint pain, swelling of glands in the neck, armpits, or groin
• Swelling, sometimes affecting the face or area around the mouth (angioedema), causing difficulty breathing, collapse. If any of these symptoms occur, seek immediate medical advice. You must stop taking Ramoclav.

Inflammation of the large intestine
Inflammation of the large intestine causing watery diarrhoea containing blood and mucus, abdominal pain and (or) fever.
If any of these symptoms occur, contact your doctor as soon as possible for advice.

Very common adverse reactions
May affect more than 1 in 10 people

• Diarrhoea (in adults)

Common adverse reactions
May affect less than 1 in 10 people

• Fungal infection (candidiasis) of the vagina, mouth (thrush), or skin folds
• Nausea, especially when taking high doses → if this occurs, take Ramoclav before meals
• Vomiting
• Diarrhoea (in children)

Uncommon adverse reactions
May affect no more than 1 in 100 people

• Rash, itching
• Raised, itchy skin lesions (urticaria)
• Indigestion
• Dizziness
• Headache

Uncommon adverse reactions that may be observed in blood laboratory test results:

• Increased activity of certain substances (enzymes) produced in the liver, which may indicate liver damage.

Rare adverse reactions
May affect no more than 1 in 1000 people

• Rash which may appear as blisters and look like target-shaped lesions (dark spots in the centre surrounded by a lighter ring with a dark rim around the edge – erythema multiforme). If any of these symptoms occur, contact your doctor immediately.

Rare adverse reactions affecting blood laboratory test results:

• Low number of blood cells involved in blood clotting (platelets)
• Low number of white blood cells.

Other adverse reactions
Other adverse reactions occurred in a very small number of patients, but their exact frequency is unknown.

• Allergic reactions (see above)

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• Inflammation of the large intestine (see above)
• Inflammation of the protective membranes surrounding the brain (aseptic meningitis)
• Severe skin reactions:
  o Widespread rash, within which blisters and skin peeling may occur, particularly around the mouth, nose, eyes, and genital organs (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (over 30% of body surface area – toxic epidermal necrolysis)
  o Widespread red rash, within which small pus-filled blisters may appear (bullous pemphigoid)
  o Red, scaly rash with subcutaneous nodules and blisters (acute generalized exanthematous pustulosis)
  o Flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results [including increased white blood cell count (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS)

If any of these symptoms occur, seek immediate medical advice.

• Hepatitis (liver inflammation)
• Jaundice caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• Inflammation of the kidney tubules
• Prolonged blood clotting time
• Restlessness
• Seizures (in people receiving high doses of Ramoclav or with kidney disease)
• Black, hairy-looking tongue
• Tooth discoloration (in children), which can usually be removed by brushing.

Adverse reactions that may appear in patient blood or urine test results:

• Marked decrease in white blood cell count
• Low number of red blood cells (haemolytic anaemia)
• Crystals in urine.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ramoclav

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
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Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ramoclav contains

• The active substances are amoxicillin and clavulanic acid. One coated tablet contains 1004.3 mg of amoxicillin trihydrate, equivalent to 875 mg of amoxicillin, and 148.9 mg of potassium clavulanate, equivalent to 125 mg of clavulanic acid.
• Other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch (type A), anhydrous colloidal silicon dioxide, povidone K 30, basic butyl methacrylate copolymer, magnesium stearate, coating: polyethylene glycol 400, hypromellose 6cP, titanium dioxide (E 171), talc, polyethylene glycol 400.

What Ramoclav looks like and contents of the pack
White to off-white, capsule-shaped coated tablets, engraved with “RX509” on one side and a score line on the other.
The pack contains 14 or 21 tablets in a blister made of PVC/PVDC/Al, in a pouch made of Polyester/Al/Polyester/Polyethylene, with a desiccant sachet containing a moisture-absorbing agent.
Do not swallow the desiccant contained inside the sachet.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Terapia S.A., Str. Fabricii nr. 124, Cluj Napoca, Romania
Manufacturer:
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH, Hoofddorp, The Netherlands
Terapia SA, Str. Fabricii nr. 124, Cluj Napoca, Romania
ALKALOIDA Chemical Company Zrt., Kabay János u. 29., Tiszavasvári, 4440, Hungary
Ecopharm EOOD, 14 Cherni vrah Blvd., bl. 3, parter, 1421, Sofia, Bulgaria
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Romania, country of export: 12777/2019/04
12777/2019/07
12777/2019/09
Parallel import authorisation number: 15/22
Medical advice
Antibiotics are used to treat bacterial infections. They are ineffective in treating viral infections.
Sometimes bacterial infections do not respond to antibiotic treatment. One of the most common reasons is that the bacteria causing the infection are resistant to the antibiotic being used. This means that bacteria can survive, and even multiply, despite antibiotic therapy.
Bacteria may become resistant to antibiotics for various reasons. Prudent use of antibiotics may help reduce the risk of development of antibiotic resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Observing the following advice will help prevent the development of resistant bacteria, which could lead to failure of antibiotic therapy.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the appropriate number of days. Please read the instructions provided in the package leaflet carefully. If any of them are unclear, ask your doctor or pharmacist for clarification.
2. The patient should not take an antibiotic that has not been prescribed specifically for them. It should be taken only to treat the infection for which it was prescribed.
3. The patient should not take an antibiotic prescribed for another person, even if they have a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If any antibiotic remains after completing the treatment as directed by the doctor, return it to the pharmacy for proper disposal.

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